[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05285111":3,"trial-entities:NCT05285111":93,"trial-summary:NCT05285111":97},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":39,"secondary_outcomes":47,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":71,"locations":74,"central_contacts":89,"overall_officials":90,"references":91,"see_also_links":92},"NCT05285111","22-001","Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates","RECRUITING","2026-12","2025-09","2025-10-02","2021-09-01","Auburn University","OTHER",false,"Project RISE is a randomized control trial. The intervention consists of four modules that focus on multiple aspects of interoception including: body awareness, body sensations\u002Fmovement, eating, health and self-care, emotional awareness, and understanding the self in relation to others. The comparator condition is called \"Health Habits\" and is matched for time and attention; participants complete modules related to healthy habits such as financial planning, hygiene, stretching, and healthy eating. Variables of interest include self-report measures of interoception, eating pathology, suicidality, physiological measures of interoception (electrocardiograph; ECG; pain tolerance measured via algometer), and an implicit association test (IAT) with death and life stimuli (meant to measure implicit associations with suicidality). The population will be college students, with current or past suicidality or low interoception.",null,[18,19],"Suicidal Ideation","Eating Disorder Symptom",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},200,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Reconnecting to Internal Sensations and Experiences","The intervention consists of four modules that focus on multiple aspects of interoception including: body awareness, body sensations\u002Fmovement, eating, health and self-care, emotional awareness, and understanding the self in relation to others.",[34],"Interoceptive Awareness",{"type":30,"name":36,"description":37,"armGroupLabels":38},"Healthy Habits","The comparator condition is called \"Health Habits\" and is matched for time and attention; participants complete modules related to healthy habits such as financial planning, hygiene, stretching, and healthy eating.",[36],[40,44],{"measure":41,"description":42,"timeFrame":43},"Multidimensional Assessment of Interoceptive Awareness","Assessment of Interoceptive Awareness. Total scores range from 0-175. Higher scores indicate a better outcome.","within one week of Post-test",{"measure":45,"description":46,"timeFrame":43},"Treatment acceptability","Feasibility and Acceptability questions. Scores range from 4-28. Higher scores indicate a better outcome.",[48,51,54,57],{"measure":49,"description":50,"timeFrame":43},"Depression Screening Inventory-Suicidality Subscale","Measure of suicidal ideation, greater scores indicate more severe ideation. Scores range from 0-12. Higher scores indicate more suicidality, or a worse outcome.",{"measure":52,"description":53,"timeFrame":43},"Eating Disorder Examination Questionnaire","Measure of disordered eating. Global score ranges from 0-6; greater scores indicate more severe eating disorder symptoms",{"measure":55,"description":56,"timeFrame":43},"Heartbeat perception task","Measured via ECG. Perceived versus actual heartbeats are recorded across 3 trials. Scores range from 0-1; higher scores indicate greater cardiac interoceptive accuracy.",{"measure":58,"description":59,"timeFrame":43},"Brief Symptom Inventory","Short measure assessing anxiety and depression symptoms. Scores range from 0-72; greater scores indicate more pathology","ALL","18 Years","65 Years",true,{"inclusion":65,"exclusion":69,"raw_text":70},[66,67,68],"Low interoceptive awareness","History of suicidal ideation or attempt","18 or older",[],"Inclusion Criteria:\n\n* Low interoceptive awareness\n* History of suicidal ideation or attempt\n* 18 or older\n\nExclusion Criteria:\n\n\\*Below the age of 18",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":12,"status":7,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":86},"Auburn","Alabama","36849","United States",[81],{"name":82,"role":83,"phone":84,"email":85},"April R Smith, PhD","CONTACT","3348447011","ars0152@auburn.edu",{"lat":87,"lon":88},32.60986,-85.48078,[],[],[],[],{"nct_id":4,"conditions":94,"biomarkers":96},[95,18],"Eating Disorder",[],{"nct_id":4,"found":63,"summary":98,"prompt_version":108},{"design":99,"status":100,"heading":101,"summary":102,"follow_up":103,"word_count":104,"commitments":105,"compensation":106,"drugs_mentioned":107},"This is a randomized control trial, meaning participants will be randomly assigned to one of two groups. It aims to enroll 200 participants.","completed","Project RISE: Reconnecting to Internal Sensations and Experiences for Suicidal Ideation and Eating Disorder Symptoms","This study, called Project RISE, is testing a behavioral program called \"Reconnecting to Internal Sensations and Experiences\" to see if it can help young adults (ages 18-65) who have had suicidal thoughts or attempts and\u002For symptoms of an eating disorder. This program focuses on improving your awareness of your body and emotions. It's being compared to another program called \"Healthy Habits\" which covers topics like financial planning and healthy eating. Researchers will measure how well you understand your body's signals and how acceptable the program is to you. The study is currently unclear on its recruitment status and plans to enroll 200 participants.","Your body awareness and treatment acceptability will be measured within one week after the program ends.",103,"Not specified in the trial record.","Not stated in the trial record.",[31,36],"v2"]